NO WARRANTY
Information accessed through this web site is presented in summary and interactive form and is not exhaustive. Sepracor Inc. makes no warranties or representations as to its accuracy or completeness. This information is provided "as is" without warranty of any kind, either express or implied, including but not limited to implied warranties of merchantability, fitness for particular purpose, or non-infringement. Some jurisdictions do not allow exclusion of implied warranties so the above exclusion may not apply to you. Certain links on this site lead to sites or sources located on servers maintained by third parties over which Sepracor has no control. Sepracor makes no representation as to the accuracy or any other aspect of the information contained in or on such sites, sources or servers, nor does Sepracor necessarily endorse such sites or sources. Neither Sepracor nor its affiliates or their respective employees shall be liable in any way for any legal claims, whether in contract, tort or otherwise in any way connected with the use or performance of this web site or any information linked or referenced by this site or any other information or World Wide Web site which link to this site.
The information included in (or accessible from) this web site contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits, and successful development of the company's pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the submission, acceptance, and approval of regulatory filings; the results of clinical trials with respect to products under development; the scope of the company's patent protection with respect to such product candidates; the commercial success of Sepracor's products; the ability of the company to attract and retain qualified personnel; the performance of Sepracor's licensees; the availability of sufficient funds to continue research and development efforts; and certain other factors that may affect future operating results and are detailed in the company's periodic reports filed with the Securities and Exchange Commission.
NON-COMMERCIAL USE
Sepracor gives you permission to copy pages of XOPENEX® or XOPENEX HFA® documents published herein on the World Wide Web for non-commercial use only, provided any copy of these documents that you make shall retain all copyright and other proprietary notices and any disclaimers contained herein.
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The information provided via this web site concerning medical products is not complete and should not be used as a substitute for a consultation or visit with a physician or other health care provider. Should you have any health care related questions, please see your physician or other health care provider promptly.
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©2007 Sepracor Inc. All rights reserved |
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Patient Prescribing Information
XOPENEX® (levalbuterol HCl) Inhalation Solution
0.31 mg,* 0.63 mg,* 1.25 mg*
*Potency expressed as levalbuterol
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
Patient Information about XOPENEX
What is XOPENEX used for?
XOPENEX (Zō–pen-eks) is used to treat or prevent narrowing of airways (bronchospasm) in patients 6 years of age and older with reversible obstructive airway disease, such as asthma.
What are the symptoms of bronchospasm?
Symptoms of bronchospasm include: coughing, wheezing, chest tightness, and shortness of breath.
Who should not take XOPENEX?
You should not take XOPENEX if you have had any type of reaction (hypersensitivity) to levalbuterol or albuterol.
Special Warnings Concerning XOPENEX:
Like other inhaled beta-agonists, XOPENEX Inhalation Solution can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.
Your health care provider may need to prescribe other medications in addition to XOPENEX to help control your asthma. Do not stop taking other asthma medications unless advised by your health care provider.
XOPENEX can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your doctor will determine if XOPENEX is right for you.
Use as directed by your doctor or health care provider. Deaths have been reported with similar inhaled medications in asthma patients who use too much medication.
Hypersensitivity reactions (severe allergic reactions) may occur immediately after taking XOPENEX. If you experience itching, areas of skin swelling (angioedema), skin rash, or narrowing of the airways, these may be signs of a hypersensitivity reaction. Seek immediate medical attention if this happens.
If you find that treatment becomes less effective, your symptoms become worse and/or you need to use the product more frequently than usual, you should seek medical attention immediately.
General Precautions with XOPENEX:
If you currently have, or have had, a history of the following conditions, your health care provider will evaluate you to decide if XOPENEX is right for you:
- heart disease (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat)
- seizures
- high levels of thyroid hormone
- diabetes
- reactions to medications similar to XOPENEX
What should I tell my doctor or health care provider?
Review all medications that you are taking with your health care provider, including those that you take without prescription. Because of the potential to interact with XOPENEX and cause side effects, tell your doctor if you are taking other medications such as:
- diuretics, such as furosemide and HCTZ (hydrochlorothiazide)
- antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants
- drugs known to affect the heart’s regular rhythm
- drugs used for high blood pressure or after a heart attack, such as metoprolol or atenolol
Tell your doctor if you are trying to become pregnant, are already pregnant, or are nursing.
What are some possible side effects of XOPENEX? (This is not a complete list of side effects reported with XOPENEX. Your health care provider can discuss with you a more complete list of side effects.)
Side effects of XOPENEX may depend on dose. XOPENEX may result in a temporary increase in heart rate, tremors, or nervousness.
How is XOPENEX taken?
XOPENEX Inhalation Solution is administered by the use of a nebulizer (NEB-yoo-ly-zer). A nebulizer is a device that converts XOPENEX Inhalation Solution into a fine mist that can be inhaled. Your doctor will instruct you on the correct use of your nebulizer and also give you written instructions. It is very important that you take your XOPENEX as directed by your physician.
Xopenex Inhalation Solution Patient's Instructions for Use
How is XOPENEX stored?
Store XOPENEX in the protective foil pouch at room temperature (68°F - 77°F). Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the pouch is opened, the vials should be used within two weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within one week. Discard any vial if the solution is not colorless.
What are the inactive ingredients in XOPENEX Inhalation Solution?
The inactive ingredients are water, sodium chloride, and sulfuric acid.
How can I find out more about XOPENEX?
Talk to your doctor. Your doctor is the best source of information, or you can call the Sepracor Customer Assistance Center at 1-888-394-7377.
Ask your doctor for the complete prescribing information and the attached Patient's Instructions for Use. This information is also available at www.xopenex.com.
September 2007
Sepracor Inc.
Marlborough, MA 01752
XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
Patient Information about XOPENEX HFA
For Oral Inhalation Only
What is XOPENEX HFA used for?
XOPENEX (Zō–pen-eks) HFA is used to treat or prevent narrowing of airways (bronchospasm) in patients 4 years of age and older with reversible obstructive airway disease, such as asthma.
What are the symptoms of bronchospasm?
Symptoms of bronchospasm include: coughing, wheezing, chest tightness, and shortness of breath.
Who should not take XOPENEX HFA?
You should not take XOPENEX HFA if you have had any type of reaction (hypersensitivity) to levalbuterol, albuterol, or any other component of XOPENEX HFA.
Special Warnings Concerning XOPENEX HFA:
Like other inhaled beta-agonists, XOPENEX HFA can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.
Your health care provider may need to prescribe other medications in addition to XOPENEX HFA to help control your asthma. Do not stop taking other asthma medications unless advised by your health care provider.
XOPENEX HFA can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your doctor will determine if XOPENEX HFA is right for you.
Use as directed by your doctor or health care provider. Deaths have been reported with similar inhaled medications in asthma patients who use too much medication.
Hypersensitivity reactions (severe allergic reactions) may occur immediately after taking XOPENEX HFA. If you experience itching, areas of skin swelling (angioedema), skin rash, or narrowing of the airways, these may be signs of a hypersensitivity reaction. Seek immediate medical attention if this happens.
If you find that treatment becomes less effective, your symptoms become worse and/or you need to use the product more frequently than usual, you should seek medical attention immediately.
General Precautions with XOPENEX HFA:
If you currently have, or have had, a history of the following conditions, your health care provider will evaluate you to decide if XOPENEX HFA is right for you:
- heart disease (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat)
- seizures
- high levels of thyroid hormone
- diabetes
- reactions to medications similar to XOPENEX HFA
What should I tell my doctor or health care provider?
Review all medications that you are taking with your health care provider, including those that you take without prescription. Because of the potential to interact with XOPENEX HFA and cause side effects, tell your doctor if you are taking other medications such as:
- diuretics, such as furosemide and HCTZ (hydrochlorothiazide)
- antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants
- drugs known to affect the heart’s regular rhythm
- drugs used for high blood pressure or after a heart attack, such as metoprolol or atenolol
Tell your doctor if you are trying to become pregnant, are already pregnant, or are nursing.
What are some possible side effects of XOPENEX HFA? (This is not a complete list of side effects reported with XOPENEX HFA. Your health care provider can discuss with you a more complete list of side effects.)
Side effects of XOPENEX HFA may depend on the number of actuations used within a given time period. XOPENEX HFA may result in a temporary increase in heart rate, tremors, or nervousness.
How is XOPENEX HFA taken?
XOPENEX HFA is administered by the use of a pressurized metered-dose inhaler, which produces a fine mist that can be inhaled. Your doctor will instruct you on the correct use of your metered-dose inhaler and also give you written instructions. The usual dose of XOPENEX HFA is 2 inhalations repeated every 4 to 6 hours. One inhalation every four hours may be sufficient in some patients. It is very important that you use XOPENEX HFA as directed by your doctor.
Xopenex HFA Patient's Instructions for Use
How is XOPENEX HFA stored?
Store XOPENEX HFA at room temperature (68°F - 77°F). Protect from freezing temperatures and direct sunlight. Store with the actuator (mouthpiece) down. The contents are under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Avoid spraying in eyes. Keep out of reach of children.
What are the inactive ingredients in XOPENEX HFA?
The inactive ingredients are propellant HFA-134a (1,1,1,2-tetrafluoroethane), dehydrated alcohol USP, and oleic acid NF.
How can I find out more about XOPENEX HFA?
Talk to your doctor. Your doctor is the best source of information, or you can call the Sepracor Customer Assistance Center at 1-888-394-7377.
Ask your doctor for the complete prescribing information and the attached Patient’s Instructions for Use. This information is also available at www.xopenex.com.
September 2007
Sepracor Inc.
Marlborough, MA 01752
